1. Field of the Invention
Multiple sclerosis (MS, also known as disseminated sclerosis or encephalomyelitis disseminata) is a disease in which the fatty myelin sheaths around the axons of the brain arid spinal cord are damaged, leading to demyelination and scarring as well, as a broad spectrum of signs and symptoms. Disease onset usually occurs in young adults. It has a prevalence that ranges between 2 and 150 per 100,000.
1. Description of Related Art
MS affects the ability of nerve cells in the brain and spinal cord to communicate with, each other. Nerve cells communicate by sending electrical signals called action potentials down long fibers called axons, which are wrapped in an insulating substance called myelin. In MS, the body's own immune system attacks and damages the myelin. When myelin is lost, the axons can no longer effectively conduct signals. Although much is known about the mechanisms involved in the disease process, the cause remains unknown. Theories include genetics or infections. Different environmental risk factors have also been found.
Several subtypes, or patterns of progression, have been described. Subtypes use the past course of the disease in an attempt to predict the future course. They are important not only for prognosis but also for therapeutic decisions. In 1996 the United States National Multiple Sclerosis Society standardized four subtype definitions:                relapsing remitting,        secondary progressive,        primary progressive, and        progressive relapsing.        
The relapsing-remitting subtype is characterized by unpredictable relapses followed by periods of months to years of relative quiet (remission) with no new signs of disease activity. Deficits suffered during attacks may either resolve or leave sequelae, the latter being more common as a function of time. This describes the initial course of 85-90% of individuals with MS. When deficits always resolve between attacks, this is sometimes referred to as benign MS, The relapsing-remitting subtype usually begins with a clinically isolated syndrome (CIS). In CIS, a patient has an attack suggestive of demyelination, but does not fulfill the criteria for multiple sclerosis. However, up to 70% of persons experiencing CIS later develop MS.
Secondary progressive MS (sometimes called “galloping MS”) describes around 65% of those with an initial relapsing-remitting MS, who then begin to have progressive neurologic decline between acute attacks without any definite periods of remission. Occasional relapses and minor remissions may appear. The median time between disease onset and conversion from relapsing-remitting to secondary progressive MS is 19 years.
The primary progressive subtype describes the approximately 10-15% of individuals who never have remission after their initial MS symptoms. It is characterized by progression of disability from onset, with no, or only occasional and minor, remissions and improvements. The age of onset for the primary progressive subtype is later than for the relapsing-remitting, but similar to mean age of progression between the relapsing-remitting and the secondary progressive. In both cases it is around 40 years of age.
Progressive relapsing MS describes those individuals who, from onset, have a steady neurologic decline but also suffer clear superimposed attacks.
Cases with non-standard behavior have also been described. Sometimes referred to as borderline forms of multiple sclerosis, these include Devic's disease. Balo concentric sclerosis, Schilder's diffuse sclerosis and Marburg multiple sclerosis.
Multiple sclerosis can be difficult to diagnose since its signs and symptoms may be similar to other medical problems. Medical organizations have created diagnostic criteria to ease and standardize the diagnostic process for practicing physicians, especially in the first stages of the disease. Historically, the Schumacher and Poser criteria were both popular (Poser et al. (2004), “Diagnostic criteria for multiple sclerosis: an historical review”. Clin Neurol Neurosurg 106 (3): 147-58). Currently, the McDonald criteria focus on a demonstration with clinical, laboratory and radiologic data of the dissemination of MS lesions in time and space (Polman et al. (2005). “Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria””, Ann. Neurol 58 (6): 840-6).
Since no known test is perfectly specific to MS, only biopsies or post-mortem, examinations can yield an absolutely certain diagnosis.
Thus, there is a need for a diagnostic tool for diagnosing multiple sclerosis. Further, there is a need for a medicament for the treatment of sclerosis.
The present invention addresses the need for a diagnostic tool for the above-mentioned family of diseases. The present invention further addresses the need for a medicament for treating the above-mentioned diseases.